Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects.

ABSTRACT:

Introduction

To assess the safety, tolerability and pharmacokinetics of a single dose of SYHA1402 in healthy Chinese subjects.

Methods

This was a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects. Subjects received a single dose of SYHA1402 25 mg, 50 mg, 100 mg, 200 mg, 400 mg or 800 mg, or matching placebo. Safety and tolerability were assessed throughout the study. The pharmacokinetic (PK) parameters of SYHA1402 were estimated using non-compartmental analysis.

Results

In all, 54 subjects were enrolled and completed the study. Specifically, there were no deaths, serious adverse events or withdrawals from study due to adverse events. All treatment-emergent adverse events were mild. The most common drug-related adverse event

SUBMITTER: Liang B 

PROVIDER: S-EPMC10195956 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature